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    K Number
    K070749
    Device Name
    ESTECH PERCUTANEOUS INSERTION DILATOR KIT
    Manufacturer
    COOMBS MEDICAL DEVICE CONSULTING
    Date Cleared
    2007-10-24

    (219 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    COOMBS MEDICAL DEVICE CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECH Percutaneous Insertion Dilator Kit is intended for use in surgical procedures to aid in percutaneous insertion of a catheter or cannula.
    Device Description
    The Estech Percutaneous Dilator Insertion Kit is a sterile, single-use, physicians convenience kit to dilate blood vessels to allow for the insertion of large diameter catheters. The kit consists of seven pieces: - 1. One 18 gage stainless steel insertion needle - 2. One stainless steel 0.035" or 0.038" guidewire - 3. Five plastic dilators, sized 8, 12, 16, 20 and 24 Fr. These pieces may be packaged, sterilized and sold separately.
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